MAUDE Adverse Event Report: GENZYME CORPORATION(RIDGEFIELD) SYNVISC; MOZ

Lot Number 7RSP007

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Local Reaction (2035); Arthralgia (2355); No Code Available (3191)

Event Date 01/25/2019

Event Type  Injury  

Manufacturer Narrative

Sanofi company comment dated (b)(4) 2019: this case concerns a patient who was on treatment with hylan g-f 20, sodium hyaluronate (synvisc) and required intervention for local knee reaction and limited mobility in knee.The plausible causal role of the device cannot be denied, however, more information regarding patient's concurrent clinical presentation, relevant medical history, past drugs, concomitant medications and other risk factors are required for further case assessment.

Event Description

Limited mobility in knee [injected limb mobility decreased].Local knee reaction [local reaction].Knee joint effusion [joint effusion].Knee pain [knee pain].Case narrative: this case is linked to case (b)(4) (same reporter).Initial information received on (b)(6) 2019 from (b)(6) regarding an unsolicited valid non-serious case received from a physician.This case involves a male patient who experienced limited mobility in knee, local knee reaction, knee joint effusion and knee pain (latency: unknown), while he was treated with hylan g-f 20, sodium hyaluronate (synvisc).The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On an unknown date, patient started treatment with intra-articular injection of hylan g-f 20, sodium hyaluronate at the dose of 1 df at unknown frequency (batch number: unknown) for knee disorder nos.It was reported that the first and second injection were tolerated well.On (b)(6) 2019 in the morning, patient received third intra-articular injection of hylan g-f 20, sodium hyaluronate at dosage of 1 df (frequency: unknown) (lot 7rsp007) for knee disorder nos.On the same day in the evening, patient experienced local knee reaction, knee joint effusion and knee pain and limited mobility in knee (latency: unknown).Patient received cortisone injection as corrective treatment for all these events and recovered from them on an unknown date in (b)(6) 2019.Corrective treatment: cortisone for all events.Outcome: recovered/resolved for all events.A product technical complaint was initiated and results were pending for the same.Seriousness criteria: intervention required for all events.Additional information was received on (b)(6) 2019 from physician.Action taken for suspect was updated from unknown to not applicable.Corrective treatment for all events was updated.Clinical course updated.Text amended accordingly.

Event Description

Limited mobility in knee [injected limb mobility decreased] local knee reaction [local reaction] knee joint effusion [joint effusion] knee pain [knee pain] case narrative: upon internal review on (b)(6) 2019, this case initially assessed as non-serious was upgraded to serious as seriousness criterion of required intervention was added for all events.This case is linked to case (b)(4).Initial information received on 25-jan-2019 from germany regarding an unsolicited valid non-serious case received from a physician.This case involves a male patient who experienced limited mobility in knee, local knee reaction, knee joint effusion and knee pain (latency: unknown), while he was treated with hylan g-f 20, sodium hyaluronate (synvisc).The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On an unknown date, patient started treatment with intra-articular injection of hylan g-f 20, sodium hyaluronate at the dose of 1 df at unknown frequency (batch number: unknown) for knee disorder nos.It was reported that the first and second injection were tolerated well.On (b)(6) 2019 in the morning, patient received third intra-articular injection of hylan g-f 20, sodium hyaluronate at dosage of 1 df (frequency: unknown) (lot 7rsp007) for knee disorder nos.On the same day in the evening, patient experienced local knee reaction, knee joint effusion and knee pain and limited mobility in knee (latency: unknown).Patient received cortisone injection as corrective treatment for all these events and recovered from them on an unknown date in (b)(6) 2019.Corrective treatment: cortisone for all events.Outcome: recovered/resolved for all events.Seriousness criteria: intervention required for all events.A product technical complaint was initiated on (b)(6) 2019 for synvisc.Batch number: 7rsp007 global ptc number: (b)(4)> the production and quality control documentation for lot # 7rsp007 expiration date (2020-05-31) was reviewed.The investigation showed that the product met specifications.No associated non-conformances were noted.Based on the lot # batch record review & lot # frequency analysis for lot # 7rsp007 no capa is required.Sanofi global pharmacovigilance and epidemiology continuously monitors adverse event reports with or without lot numbers, and assesses possible associations with their corresponding product lot, as part of routine safety surveillance effort to detect safety signals.This review did not indicate any safety issue.As of (b)(6) 2019, there were 12 complaints on file for lot # 7rsp007 and all related sublots: 11 complaints are on file for lot # 7rsp007b: (1) adverse event reports (2 syringes), (1) damaged packaging, (1) tip breakage, (6) adverse event reports and (2) leaky syringes.1 complaint is on file for lot# 7rsp007: (1) adverse event report.Sanofi would continue to monitor complaints to determine if a capa was required.Additional information was received on 29-jan-2019 from physician.Action taken for suspect was updated from unknown to not applicable.Corrective treatment for all events was updated.Clinical course updated.Text amended accordingly.Additional information received on 11-feb-2019.Investigation summary received and ptc results added.Text amended accordingly.

• Brand Name: SYNVISC
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• MDR Report Key: 8307561
• MDR Text Key: 135150314
• Report Number: 2246315-2019-00040
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 02/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Lot Number: 7RSP007
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/05/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention